CTRI

Postoperative nausea and vomiting (PONV) is a common cause of morbidity following abdominal surgeries, particularly laparoscopic cholecystectomy. PONV is defined as nausea and vomiting seen in the first 24hours after surgery. Despite advances in anesthetic techniques and antiemetic medications, PONV rates can range from 25% to 42% without prophylactic intervention. These complications pose a burden for patients, anesthetist, surgeons, and healthcare systems. Patients experience discomfort, delayed recovery and potential complications like aspiration pneumonia, Hospitals incur increased costs and resource utilization associated with prolonged hospital stays.

Previous studies have used methylprednisolone in higher dose of 2.5mg/kg. but very few studies have assessed the efficacy of low dose methylprednisolone <1mg/kg in preventing PONV. In our study we plan to use low dose methylprednisolone of single dose of 40mg irrespective of body weight to prevent PONV. Additionally, the lower cost and well-tolerated nature of low-dose methylprednisolone offer potential advantages in resource-limited settings and for patients with specific medical conditions.

Thus, in our proposed prospective randomized, non-inferiority trial, we aim to provide an evaluation of comparison of ondansetron with low-dose methylprednisolone as a viable alternative to dexamethasone along with ondansetron for preventing PONV following laparoscopic cholecystectomy, addressing concerns related to efficacy, safety, and cost-effectiveness.

Study Design: This will be a prospective, randomized triple blinded, parallel armed controlled trial with non-inferiority design to compare the efficacy and safety of low-dose methylprednisolone (40mg) vs dexamethasone (0.1mg/kg) along with ondansetron (4mg) in preventing PONV after laparoscopic cholecystectomy.

Subjects will be randomized via computer generated table and allocated by opaque sealed envelope method to one of the two groups.

Group M (n=40): Received low-dose methylprednisolone{40mg} and ondansetron {4mg} before surgery.

Group D (n=40): Received dexamethasone {0.1mg/kg} and ondansetron{4mg} before surgery.

Premedication will be done using Alprazolam 0.25mg orally the night before surgery, Pantoprazole 40mg orally on the morning of surgery NPO status and consent will be confirmed on the morning of surgery, Peripheral IV cannula will be placed, Vital signs will be monitored (NIBP, HR, ECG, SpO2, EtCO2) Baseline recordings will be noted. Premedication will be administered with Glycopyrrolate 10 mcg/kg IV, Ondansetron 4mg IV, Midazolam 1mg IV will be administered, On pre induction Group M patient will receive IV methylprednisolone 40mg IV & ondansetron 4 mg, Group D patient will receive IV dexamethasone 0.1mg/kg & ondansetron 4 mg. Induction will be done using Fentanyl 2 mcg/kg IV, Propofol 2mg/kg IV slowly, Atracurium 0.5mg/kg IV, Ventilation will be done with bag-mask for 3 minutes followed by Direct laryngoscopy and intubation with appropriate-sized Macintosh blade and endotracheal tube Confirmation of air entry in both lungs. Patient will be Maintained on 50% air-oxygen mixture and isoflurane titrated and kept to MAC between 1.0 and 1.2 and injection atracurium 0.1mg/kg at regular interval.

Surgery will be performed by four-port standard laparoscopic cholecystectomy technique and at the end of procedure standard reversal protocol will be followed. Multi-modal analgesia will be administered to all patients with port site infiltration with local anesthetic, IV diclofenac 75mg and IV paracetamol 1gram infusion and inj. metoclopramide 10mg IV slowly over 10min will be used as rescue anti-emetics if required.